1Other quality system
Written procedures for sampling and testing plans are not followed for each drug product.
Inspection Record
Impax Laboratories, Inc. — FDA 483 Findings
Inspectors William V. Millar · Peter E. BakerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations ofa failure ofa batch or any of its components to meet any ofits specifications did not extend to other batches ofthe same drug product.
3Other quality system
Drug products failing to meet established standards and specifications are not rejected.
4Deviation, CAPA, and investigation
Written records are not made ofinvestigations into unexplained discrepancies and the failure ofa batch or any of its components to meet specifications.
5Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
